Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

FDA Warns Devicemaker Over MDR, GMP Violations

An inspection in March by the FDA of ELITech Group’s facility in Spankeren, The Netherlands prompted a warning letter after the device manufacturer failed to follow through with the promises made in response to a Form 483 report.

The agency said the firm’s Selectra Pro S, Selectra Pro M and Viva Junior Analyzer devices were misbranded because the firm lacked adequate medical device reporting procedures and failed to report corrections or removals to the FDA.

GMP violations noted in the 483 resulted in the devices also being deemed adulterated. The violations include placing a CAPA in a postponed stage without any documentation for the practice, and failing to investigate complaints associated with rust residue, a burnt out power connect, and leaking units.

The agency also flagged inadequate processes for validating the facility’s water system, and controlling purchased products and accepting incoming products.